Laparoscopic tool with obturator

ABSTRACT

A laparoscopic device with obturator. The device facilitates extraction of specimens from a female subject&#39;s abdominal cavity through the subject&#39;s vagina by also facilitating the suturing of a mesh to the anterior and posterior walls of the subject&#39;s vagina. The device includes an elongate sheath that has a flat surface on the front, a curved shape on the back, and an inner port opening formed within the flat surface, where the port opening that enables introduction of instruments or removal of specimens from the peritoneal cavity. An internal obturator can be inserted into the sheath to reduce the size of the port opening into the peritoneal cavity, or can be used to close the inner port opening into the peritoneal cavity. The obturator and sheath can be utilized as firm surfaces against which a user can suture a sacrocolpopexy mesh to the anterior and posteriors vaginal walls.

CROSS-REFERENCE TO RELATED APPLICATIONS

This non-provisional application is a continuation of currently pendingPCT application No. PCT/US2014/014894, entitled “Laparoscopic Tool withObturator”, filed Feb. 5, 2014, which claims priority to provisionalapplication No. 61/760,983, entitled “Vaginal Port with Obturator”,filed Feb. 5, 2013, the contents of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates, generally, to laparoscopic instrumentation anduse. More particularly, it relates to endoscopic devices for use intransvaginal laparoscopic surgeries, such as procedures to correctprolapse in female patients (e.g., sacrocolpopexy, sacrohysteropexy, andsimilar procedures).

2. Description of the Prior Art

Minimally invasive laparoscopic techniques have been developed in orderto avoid large skin incisions associated with traditional surgery,involving use of small incisions (each about 5-12 mm in diameter) in thepatient's abdominal wall, in which surgical instruments are inserted.These surgical instruments may be used to dissect and remove tissues andorgans (i.e., specimens) that can be several centimeters in diameter.Such minimally invasive surgical techniques have been evolving for morethan 100 years, since Georg Kelling performed the first experimentallaparoscopy in 1901. (Litynski, G. Endoscopic surgery, the history, thepioneers. World J. Surg. 1999 August; 23(8):745-53). These minimallyinvasive laparoscopic surgeries result in less post-operative pain,quicker recovery and an improved cosmetic appearance for patientscompared to traditional laparotomy. Currently, hybrid procedurescombining flexible endoscopy and laparoscopy, such as intraoperativeenteroscopy and laparoscopic-assisted endoscopic retrogradecholangiopancreatography, are performed in increasing numbers. (Ceppa,F., et al. Laparoscopic transgastric endoscopic retrograde endoscopyafter Roux-en-Y gastric bypass. Surg. Obes. Relat. Dis. 3: 21-24 2007;Peters, M., et al. Laparoscopic transgastric endoscopic retrogradecholangiopancreatography for benign common bile duct structure afterRoux-en-Y gastric bypass. Surg. Endosc. 16:1106 2002).

One limitation, however, has been the removal of pathologic specimensthat are larger than the port sites used to perform these surgeries.Consequently, these large specimens typically must be removed from theabdominal cavity by cutting or morcellating them within the abdominalcavity or by making an incision in the abdominal wall that is largeenough to accommodate removal of the large specimen.

Further, laparoscopic instruments are typically confined to fit withinthese port sizes, thus limiting development of larger and more efficientminimally invasive surgical devices. A typical umbilicus laparoscopicport incision is no larger than 15 mm, and other support incisions areusually much smaller. Larger incisions lead to more scarring and thepotential for hernia formation. Therefore, the tools used forlaparoscopy are small in size to fit these incision limitations.

Recently, surgeons have taken advantage of natural orifices (vagina,rectum, urethra, and gastrointestinal tract) to perform Natural OrificeTransluminal Endoscopic Surgery (NOTES) procedures with good results(Bessler, M.; Gumbs, A. A.; Milone, L.; Evanko, J. C.; Stevens, P.;Fowler, D. Video. Pure natural orifice transluminal endoscopic surgery(NOTES) cholecystectomy. Surg Endosc 24: 2316-2317; 2010; Kaouk, J. H.;White, W. M.; Goel, R. K.; Brethauer, S.; Crouzet, S.; Rackley, R. R.;Moore, C.; Ingber, M. S.; Haber, G. P. NOTES transvaginal nephrectomy:first human experience. Urology 74: 5-8; 2009; Pearl, J., Ponsky, J.,Natural orifice transluminal endoscopic surgery: past present andfuture. J Min. Ace. Surg. 3:2 43-46 2008; Wilk, P., U.S. Pat. No.5,297,536). NOTES has been used for diagnostic and therapeuticprocedures including organ removal, though current articulatinginstruments for use with NOTES are disposable, increasing costs comparedto standard laparoscopic procedures, and removal of large tumors orsolid organs cannot be performed using NOTES (Dapri, Single accesslaparoscopic surgery: Complementary or alternative to NOTES? World JGastrointest Surg. 2010 Jun. 27; 2(6): 207-9). Advantages of NOTESinclude cosmetic results; reduced anesthesia requirements; fasterrecovery and shorter hospital stays; decreased abdominal trauma andtherefore potential complications of transabdominal wound infections,such as hernias; less need for immunosuppression and pain killers; andbetter postoperative pulmonary and diaphragmantic function.

NOTES has been extensively studied in animal models, with tuballigation, gallbladder surgery, oophorectomy, hysterectomy,gastrojejunostomy, and splenectomy having been described. (Jagannath,S., et al. Peroral transgastric endoscopic ligation of fallopian tubeswith long-term survival in a porcine model. Gastrointest. Endosc. 61:449-453 2005; Experimental studies of transgastric gallbladder surgery:cholecystectomy and cholecystogastric anastomosis. Gastrointest. Endosc.61: 601-606 2005; Wagh, M. et al., Survival studies after endoscopictransgastric oophorectomy and tubectomy in a porcine model.Gastrointest. Endosc. 63: 473-478 2008; Merrifield, B., et al. Peroraltransgastric organ resection: a feasibility study in pigs. Gastrointest.Endosc. 63: 693-697 2006; Kantsevoy, S., et al. Transgastric endoscopicsplenectomy: is it possible? Surg. Endosc. 20: 522-525 2006). Thesesurgical procedures are promising advances, due to the potential toeliminate traditional surgical complications, like postoperativeabdominal wall pain, wound infections, hernias, adhesions, and impairedimmune function. (Wagh, M., Thompson, C. Surgery insight: naturalorifice transluminal endoscopic surgery—an analysis of work to date.Gastr. & Hept. 4:7 386-392 2007). Further, NOTES procedures may beperformed under conscious sedation and not general anesthesia. (Pearl,J., Ponsky, J., Natural orifice transluminal endoscopic surgery: pastpresent and future. J Min. Ace. Surg. 3:2 43-46 2008). The transluminalapproach could be particularly important for morbidly obese patients andothers at high risk for standard surgery.

The vagina is an ideal portal to access the abdominal cavity for womenundergoing minimally invasive laparoscopic surgery, and is regaininginterest in the surgical community (Auyang, E. D.; Santos, B. F.; Enter,D. H.; Hungness, E. S.; Soper, N. J. Natural orifice translumenalendoscopic surgery (NOTES®): a technical review. Surg Endosc 25:3135-3148; 2011; Stark, M.; Benhidjeb, T. Natural Orifice Surgery:Transdouglas surgery—a new concept. JSLS 12: 295-298; 2008) forperitoneal access. According to some computer generated models(Ashton-Miller, J. A.; DeLancey, J. O. Functional anatomy of the femalepelvic floor. Ann N Y Acad Sci 1101: 266-296; 2007), its elasticityallows stretching to accommodate dimensions greater than three times itsresting state. The posterior portion of the vagina also directlycommunicates with the abdomen through only a few tissue layers, and whenplaced on stretch, is distant from vital anatomic structures. Alaparoscopic port utilizing transvaginal access would increase thesurgeon's access to the abdominal cavity and provide a much largerincision site, without the concerns for hernia formation and scarring.Additionally, transvaginal removal of large specimens enables minimallyinvasive laparoscopic surgery without the need for morcellation withinthe abdominal cavity or large incisions in the abdominal wall to removethe specimens, enabling minimal scarring and faster recovery followingsurgery. Accordingly, transvaginal NOTES is considered one of the safestand feasible methods for clinical application. Totally transvaginalcholecystectomy has been experimentally performed without usinglaparoscopic assistance.

Ghezzi et al. (Ghezzi, F.; Raio, L.; Mueller, M. D.; Gyr, T.;Buttarelli, M.; Franchi, M. Vaginal extraction of pelvic massesfollowing operative laparoscopy. Surg Endosc 16: 1691-1696; 2002.) andSpuhler et al. (Spuhler, S. C.; Sauthier, P. G.; Chardonnens, E. G.; DeGrandi, P. A new vaginal extractor for laparoscopic surgery. J Am AssocGynecol Laparose 1: 401-404; 1994) described devices for the extractionof pelvic masses following laparoscopy. These devices utilized a metalshaft with a fitted rubber ball to provide vaginal occlusion and preventloss of pneumoperitoneum. Another device developed in Australia andmarketed by Gynetech Pty Ltd, uses a similar hollow tube placed in thevagina (McCartney, A. J. Transvaginal tube as an aid to laparoscopicsurgery. Google Patents; 2003). The design of this device is such thatthe tube fits around the cervix to distinguish the cervicovaginaljunction, similar to the Koh colpotomy cup already in use forhysterectomy procedures (Koh, C. H. Simplified total laparoscopichysterectomy method employing colpotomy incisions. Google Patents;1996).

However, there is a need for an improved device that utilizes the vaginaas an access to the peritoneal cavity for the introduction oflaparoscopic surgical devices or implants, or the extraction ofpathologic specimens. Accordingly, what is needed in the art is devicesthat permit enhanced access to the abdomen during surgery. However, inview of the art considered as a whole at the time the present inventionwas made, it was not obvious to those of ordinary skill how the artcould be advanced.

While certain aspects of conventional technologies have been discussedto facilitate disclosure of the invention, Applicants in no way disclaimthese technical aspects, and it is contemplated that the claimedinvention may encompass one or more of the conventional technicalaspects discussed herein.

The present invention may address one or more of the problems anddeficiencies of the prior art discussed above. However, it iscontemplated that the invention may prove useful in addressing otherproblems and deficiencies in a number of technical areas. Therefore, theclaimed invention should not necessarily be construed as limited toaddressing any of the particular problems or deficiencies discussedherein.

In this specification, where a document, act or item of knowledge isreferred to or discussed, this reference or discussion is not anadmission that the document, act or item of knowledge or any combinationthereof was at the priority date, publicly available, known to thepublic, part of common general knowledge, or otherwise constitutes priorart under the applicable statutory provisions; or is known to berelevant to an attempt to solve any problem with which thisspecification is concerned.

BRIEF SUMMARY OF THE INVENTION

The long-standing but heretofore unfulfilled need for an improvedtransvaginal laparoscopic surgical device and method is now met by anew, useful, and nonobvious invention.

In an embodiment, the current invention is a laparoscopic tool. Thelaparoscopic tool includes a tubular or ovoid elongate sheath having aproximal end (closer to the operator or clinician) and a distal end(closer to the patient or subject). The sheath has a semi-flatlongitudinal side and a curved longitudinal side enclosing aninterstitial space within the sheath. A port opening is formed in thesemi-flat side at the distal end of the sheath. The port opening has alength that is aligned or coplanar with the semi-flat side. The curvedside meets or intersects the semi-flat side at a point distal to theport opening. The laparoscopic tool further includes an elongateobturator that can be inserted into the interstitial space of thesheath. The obturator includes a shaft disposed within the interstitialspace when the obturator is inserted into the sheath. The obturatorfurther includes a head coupled to the distal end of the shaft, wherethe head is positioned within the distal end of the sheath when theobturator is inserted into the sheath. The head of the obturator has asubstantially flat side and a curved side, such that the substantiallyflat side fills at least a portion of the space or void provided by theport opening within the semi-flat side of the sheath. The curved side ofthe obturator head is positioned along and within the curved side of thesheath.

A handle may optionally be connected to the proximal end of the sheathfor controlling the laparoscopic tool.

A push-pull knob may optionally be coupled to the proximal end of theobturator shaft for pushing or pulling the obturator into and out of thesheath.

The curved side of the obturator head may optionally have a curvaturethat is substantially similar to the curvature of the curvedlongitudinal side of the sheath at the distal end of the sheath.

The obturator shaft may optionally have a diameter or width that issmaller than the width of the obturator head.

The port opening may have a teardrop shape, such that it is wider at itsdistal-most point and narrower at its proximal-most point.

In a separate embodiment, the current invention is a laparoscopic toolfor suturing a sacrocolpopexy mesh to the anterior and posterior vaginalwalls during treatment of vaginal prolapse in a female patient. Thelaparoscopic tool includes a tubular or ovoid elongate sheath having aproximal end (closer to the operator or clinician) and a distal end(closer to the patient or subject). The sheath has a semi-flatlongitudinal side and a curved longitudinal side enclosing aninterstitial space within the sheath. A teardrop-shaped port opening isformed in the semi-flat side at the distal end of the sheath, such thatit is wider at its distal-most point and narrower at its proximal-mostpoint. The port opening has a length that is aligned or coplanar withthe semi-flat side. The curved side meets or intersects the semi-flatside at a point distal to the port opening. The laparoscopic toolfurther includes an elongate obturator that can be inserted into theinterstitial space of the sheath. The obturator includes a shaftdisposed within the interstitial space when the obturator is insertedinto the sheath. The obturator further includes a head coupled to thedistal end of the shaft, where the head is positioned within the distalend of the sheath when the obturator is inserted into the sheath. Theobturator shaft has a diameter or width that is smaller than the widthof the obturator head. The head of the obturator has a substantiallyflat side and a curved side, such that the substantially flat side fillsat least a portion of the space or void provided by the port openingwithin the semi-flat side of the sheath. The curved side of theobturator head is positioned along and within the curved side of thesheath. The curvature of the curved side of the obturator head issubstantially similar to the curvature of the curved longitudinal sideof the sheath at the distal end of the sheath. The laparoscopic toolfurther includes a handle connected to the proximal end of the sheathfor controlling the laparoscopic tool. The laparoscopic tool furtherincludes a push-pull knob coupled to the proximal end of the obturatorshaft for pushing or pulling the obturator into and out of the sheath.

In a separate embodiment, the current invention is a method of treatingpelvic organ prolapse in a female patient. A laparoscopic tool isinserted into a vagina of the patient, where the laparoscopic toolincludes an elongate sheath having a semi-flat side and a curved side. Aport opening is formed in the semi-flat side. When the laparoscopic toolis inserted into the vagina, an incision is made through the portopening where desired by the user (e.g., operator, clinician, etc.). Atthis point, the peritoneal cavity of the patient can be accessed throughthe incision. An elongate obturator is inserted through the sheath toreduce the size of the port opening. The obturator includes a shaft anda head that is coupled to the distal end of the shaft. The head has asubstantially flat side and a curved side, where the substantially flatside is positioned substantially within the port opening and the curvedside is positioned along and within the distal end of the curved side ofthe sheath. A sacrocolpopexy mesh is sutured (e.g., via interruptedpermanent sutures, autosuture device) to the vagina using one or both ofthe following: the substantially flat side of the obturator, and thecurved side of the sheath. These can be used as one or more firmsurfaces against which the user can suture the sacrocolpopexy mesh tothe vagina.

The sacrocolpopexy mesh may optionally be a Y-shaped mesh with two (2)branches on an end of the Y-shaped mesh. In a further embodiment, duringinsertion of the laparoscopic tool, the semi-flat side of the sheath andthe port opening are positioned against the posterior vaginal wall ofthe patient. As such, the curved side of the sheath is positionedagainst the anterior vaginal wall of the patient. In this position, onebranch of the Y-shaped mesh can be sutured against the posterior vaginalwall using the substantially flat side of the obturator head as a firmsurface against which the user can suture the branch of the Y-shapedmesh to the posterior vaginal wall. The other branch of the Y-shapedmesh can be sutured against the anterior vaginal wall using the curvedside of the obturator head as a firm surface against which the user cansuture the branch of the Y-shaped mesh to the anterior vaginal wall.

The incision may optionally be made in the posterior cul-de-sac (i.e.,Pouch of Douglas, recto-uterine pouch) of the patient through the portopening of the laparoscopic tool in order to access the peritonealcavity of the patient.

The laparoscopic tool may optionally include a push-pull knob mayoptionally be coupled to the proximal end of the obturator shaft forpushing or pulling the obturator into and out of the sheath.

The curved side of the obturator head may optionally have a curvaturethat is substantially similar to the curvature of the curvedlongitudinal side of the sheath at the distal end of the sheath.

The obturator shaft may optionally have a diameter or width that issmaller than the width of the obturator head.

The port opening may have a teardrop shape, such that it is wider at itsdistal-most point and narrower at its proximal-most point.

These and other important objects, advantages, and features of theinvention will become clear as this disclosure proceeds.

The invention accordingly comprises the features of construction,combination of elements, and arrangement of parts that will beexemplified in the disclosure set forth hereinafter and the scope of theinvention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the invention,reference should be made to the following detailed disclosure, taken inconnection with the accompanying drawings, in which:

FIG. 1 is a side view of a transvaginal laparoscopic tool with obturatoraccording to an embodiment of the current invention.

FIG. 2 is a top view of a transvaginal laparoscopic tool with obturatoraccording to an embodiment of the current invention.

FIG. 3 is a rear view of a transvaginal laparoscopic tool with obturatoraccording to an embodiment of the current invention.

FIG. 4 is a wireframe view of an obturator within a transvaginallaparoscopic tool according to an embodiment of the current invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

In the following detailed description of the preferred embodiments,reference is made to the accompanying drawings, which form a partthereof, and within which are shown by way of illustration specificembodiments by which the invention may be practiced. It is to beunderstood that other embodiments may be utilized and structural changesmay be made without departing from the scope of the invention.

For female patients, it is possible to take advantage of the fact thatthe abdominal cavity can be accessed through the vagina. Furthermore,the vagina has sufficient elasticity, allowing it to stretch toaccommodate removal of large specimens or insertion of largerinstruments than typically seen in laparoscopic procedures through theabdomen of the patient. The underutilization of the vagina as a portalfor use during laparoscopic surgery may be due, in part, to the paucityof medical devices and instruments designed for this mode of access.While there are some vaginal colpotomizer rings and uterine manipulatorscommercially available, there are few effective devices (e.g., PCTApplication No. PCT/US2012/070147, which is incorporated herein byreference) specifically designed for use in the vagina duringlaparoscopic surgery.

This invention involves a device used during laparoscopic surgery thatis used to extract tissues or organs, referred herein as “specimens”,from a woman's abdominal cavity through the woman's vagina, or tointroduce devices or implants into the abdomen during surgery, or toprovide a firm surface for suturing. The device shaft was designed toaccommodate the average dimensions of the animal's vagina, such as ahuman, with both a straight and curved design to allow the surgeonoptimal flexibility when manipulating the device during actual use inlaparoscopic surgical procedures. The apparatus of the current inventionincludes a transvaginal laparoscopic tool with obturator that enables anoperator, user, or clinician to perform minimally invasive surgery usingthe advantages of a vaginal entry into the peritoneal cavity, while alsohaving a shape that is ideal for suturing mesh to the vagina duringprolapse surgery.

In particular, a sacrocolpopexy procedure typically uses a Y-shapedmesh, or other configuration of mesh, which is sutured to the anteriorand/or posterior vaginal wall. The mesh is sutured to the anteriorvaginal wall most effectively when a solid, semi-flat surface is used asa base or backboard in the vagina, which enables the vagina to bestretched to maximize anterior vaginal wall surface area. In this way,the mesh can lay flat on the anterior vaginal wall during suturing. Itis often quite difficult to suture the mesh on the posterior vaginalwall of a patient due to the natural angle of the vagina, which laysflat over the pelvic floor.

It is also quite difficult to access deep in the posterior cul-de-sacand suture the mesh to the perineal body. The curve on the back of thedevice allows the vagina to be lifted upwards and out of the posteriorcul-de-sac, thereby enabling safe entry of the inner port opening of thelaparoscopic tool into the peritoneal cavity, and also enabling thesurgeon to suture mesh to the posterior vaginal wall and to the perinealbody, using one multipurpose transvaginal laparoscopic tool according tothe current invention.

The obturator can be inserted into the inner port during suturing of themesh to the posterior vaginal wall during a sacrocolpopexy procedure,such that the surgeon can suture on a solid surface. The obturator canalso be used to reduce the caliber of the inner port opening, which canallow different size instruments to be inserted into the peritonealcavity without having too large or small of an opening.

Certain embodiments of the current invention include a device usedduring laparoscopic surgery that enables the surgeon to extract tissuesor organs (i.e., “specimens”) from a woman's abdominal cavity throughthe woman's vagina, but is also customizable with multiple size internalobturators. As seen in FIGS. 1-4, the device, according to an embodimentof the current invention, can include a transvaginal laparoscopic toolhaving a flat surface on the front, a curved shape on the back, and aninner port that enables introduction of instruments or removal ofspecimens from the peritoneal cavity. An internal obturator can bepositioned in the inner port to reduce the size of the distal openinginto the peritoneal cavity, or can be used to close the inner portopening into the peritoneal cavity. By closing the inner port openingwith the obturator, the transvaginal laparoscopic tool has an idealconfiguration for performance of a sacrocolpopexy procedure. It allowsthe surgeon to suture the Y-shaped mesh to the front wall of the vaginausing the front vaginal port flat surface, and to the back wall of thevagina and perineal body using the back curved vaginal port surfacesince this is an ideal configuration to access deep in the posteriorcul-de-sac.

Currently, the prior art fails to teach any transvaginal laparoscopictool that enables removal of abdominal/pelvic masses while also allowingintroduction of instruments into the peritoneal cavity. Also, currentlaparoscopic ports are limited in size, typically to 5 to 12 mm, sincelarger ports require larger incisions in the abdominal wall, whichincreases scarring, post-op pain and risk of hernia formation. Usingembodiments of the current invention with the distensibilitycharacteristics of the vagina, a significantly larger port can bedesigned to enable greater access into the peritoneal cavity than ispossible through traditional laparoscopic ports placed in the abdominalwall. This enables development of larger laparoscopic instruments, whilealso allowing the surgeon to remove significantly larger masses withouthaving to extend abdominal wall incisions or use a morcellator which hasinherent risks of injury to surrounding organs or blood vessels.

The major challenges of performing a sacrocolpopexy procedure issuturing the Y-shaped mesh to a flat surface on the front of the vagina,and then accessing deep in the posterior cul-de-sac to suture theY-shaped mesh in this area. The transvaginal laparoscopic tool withobturator device, according to the current invention, is unique in thatthe shape is ideally designed for the sacrocolpopexy procedure, whilealso working as a transvaginal laparoscopic tool. In this way, a widevariety of medical procedures can be performed utilizing one vaginalport.

Additionally, the obturator can be designed to enable a smallneedle-like device to be inserted through the vagina to hold theY-shaped sacrocolpopexy mesh in place during suturing of the mesh to theanterior and/or posterior walls of the vagina. This can also serve tostabilize the mesh in correct position on the vaginal wall, a task thatsolves another challenging aspect of the procedure.

The laparoscopic tool of the current invention, or each componentthereof, can be formed of any suitable material, for example including,but not limited to, surgical steel, plastic, and titanium.

Example 1

The laparoscopic instrument may safely facilitate entry into theabdominal cavity during laparoscopic surgery. Traditionally, peritonealaccess has been obtained by a transabdominal approach. The Veressneedle, which was originally developed to perform pleurodesis intuberculosis patients, is commonly used to access the abdominal cavityand provide pneumoperitoneum. One disadvantage is the blind placement ofthe needle into the abdomen and the risk of injury to adjacent organsand blood vessels.

One method, reported in 1971 by Harry Hasson and now called the opentechnique, has overcome this blind entry to access the peritoneal cavity(Hasson, H. M. A modified instrument and method for laparoscopy. Am JObstet Gynecol 110: 886-887; 1971). Also, some advances in opticaltrocar design have allowed for visualizing entry with the use of thelaparoscope that often, but not necessarily, requires priorpneumoperitoneum. However, these techniques continue to usetrans-abdominal entry, most commonly through the umbilicus, with theattributed risk for vital organ and vascular injury using this approach.

The laparoscopic instrument can allow for direct entry into theposterior cul-de-sac, or Pouch of Douglas, through the posterior portionof the vagina, which is perhaps the safest access site into theabdominal cavity. As the vagina is elastic, the posterior apex of thevagina is displaced away from the rectosigmoid, and provides a safeentry even in difficult surgical procedures. Combined with the relativeease of repair of the incision, colpotomy access to the abdominal cavityis safe for patients and convenient for surgeons.

FIGS. 1-4 depict a laparoscopic tool, generally denoted by the referencenumeral 10, according to an exemplary embodiment of the currentinvention. Laparoscopic tool 10 has a generally circular or ovoidcross-section. As seen in FIG. 1, laparoscopic tool 10 includes elongatesheath 11 with interstitial space 13 therewithin. Elongate sheath 11includes a first side, denoted by the reference numeral 12, and a secondside, denoted by the reference numeral 14. Laparoscopic tool 10 furtherincludes a proximal end, generally denoted by the reference numeral 16,and a distal end, generally denoted by the reference numeral 18. As usedherein, the term “proximal” refers to a location that, during normaluse, is closer to the operator or clinician using the device and fartherfrom the patient in connection with whom the device is used. Conversely,the term “distal” refers to a location that, during normal use, isfarther from the clinician using the device and closer to the patient inconnection with whom the device is used.

First side 12 is semi-flat along its surface and along port opening 30.When laparoscopic tool 10 is placed within a vagina, first side 12 andport opening 30 are positioned along or otherwise facing the posteriorvaginal wall of the patient to facilitate access into the peritoneumthrough an appropriate incision in the posterior cul-de-sac (i.e., Pouchof Douglas) through port opening 30. First side 12 can be slightlycurved to accommodate the undulations and form of the posterior vaginalwall.

Laparoscopic tool 10 further includes port opening 30 on its distal end18 within first side 12 of elongate sheath 11. Interstitial space 13 isin open communication with the external environment (i.e., exteriorspace) through port opening 30. A retractable or removable cover (notshown) can be positioned on port opening 30 to close off interstitialspace 13 when needed. Second side 14 is curved so as to meet first side12 at rounded lip 32. This type of configuration permits port opening 30to be aligned with first side 12. Rounded lip 32 forms the distal-mostpoint of laparoscopic tool 10 and thus helps prevent laparoscopic tool10 from harming anatomical structures within the patient.

Port opening 30 can have any suitable shape and size. As seen in FIG. 2,port opening 30 can be generally teardrop-shaped with a wider width atits most distal position near lip 32 and a narrower width forming apoint at its most proximal position. It can be appreciated that portopening 30 can have any suitable shape as needed or desired by a user.Examples include, but are not limited to, circular, ovular, diamond, andsquare, among other regular and irregular shapes.

Second side 14 is curved to enable easier and safer access into theperitoneal cavity to function as a vaginal laparoscopic port. Secondside 14 is also designed with a curve that enables easier access intothe posterior cul-de-sac (i.e., Pouch of Douglas). Additionally, thecurve of second side 14 conforms to the conformation of the vagina whenthe patient is in a generally supine, lithotomy position (or similarposition) utilized by a clinician to examine the pelvis or lowerabdomen. In this position, the curve of second side 14 follows the pathof the anterior vaginal wall and thus facilitates suturing of theY-shaped sacrocolpopexy mesh (e.g., via interrupted permanent sutures,autosuture device) to the anterior vaginal wall against the solidsurface of second side 14. This is particularly helpful sincesacrocolpopexy mesh is intended to stretch the vagina longitudinallytoward the sacrum.

Laparoscopic tool 10 can further include handles 28 that facilitatemanipulation and control of tool 10. Handle 28 is positioned proximal tosheath 11 on proximal end 16 of laparoscopic tool 10. Any suitablehandle or means of control can be utilized with laparoscopic tool 10.

Obturator 20, which can be best seen in FIG. 4, is an elongatesupplemental insertion component that is inserted into sheath 11 throughproximal end 16 of laparoscopic tool 10. As seen in FIG. 4, obturator 20can be formed of four main components: push/pull knob 26, connector 23,shaft 22, and head 24. When obturator 20 is inserted through sheath 11within interstitial space 13, knob 26 can be positioned proximal tohandles 28 and can be used to push or pull obturator 20 out ofinterstitial space 13 of sheath 11. Connector 23 is positioned withinthe interior of handles 28 and is connected to knob 26 on its proximalend. On its distal end, connector 23 is connected to the proximal end ofshaft 22, such that connector 23 indirectly couples knob 26 with shaft22. Alternatively, knob 26 can be coupled directly to shaft 22. Shaft 22is longitudinally disposed through interstitial space 13 of sheath 11.This coupling/affixing of components can be accomplished via any meansknown in the art, for example including, but not limited to, thermalwelding, electrical welding, soldering, or a pin hinge.

Head 24 is positioned at distal end 18 of laparoscopic tool 10 and iscoupled to the distal end of shaft 22. Shaft 22 can have a width ordiameter that is smaller than the width of head 24. This permitssurgical instruments to access the patient's peritoneal cavity throughport opening 30 even with obturator 20 inserted into sheath 11. This maybe done if the operator or clinician desires port opening 20 to have asmaller size but still needs to access the peritoneal cavity withsurgical instruments prior to blocking port opening 30 entirely.

Head 24 includes a first side, denoted by the reference numeral 34, anda second side, denoted by the reference numeral 36. First side 34 ofobturator 20 is substantially flat and is aligned with first side 12 ofsheath 11, substantially within port opening 30 when obturator 20 ispositioned within interstitial space 13 of sheath 11. Second side 36 ofobturator 20 is curved and is aligned with the curve of second side 14of sheath 11 at proximal end 18 of laparoscopic tool 10. In other words,the curve of second side 36 of obturator 20 has a similar angle, arc, orcurvature as the curve of second side 14 of sheath 11. Thisconfiguration allows head 24 to rest within distal end 18 oflaparoscopic tool 10 while minimizing the space wasted withininterstitial space 13.

Because first side 34 of obturator 20 is aligned within port opening 30of first side 12 of sheath 11, obturator 20 blocks the space provided byport opening 30. When obturator 20 is blocking at least a portion of thespace provided by port opening 30, obturator 20 can be utilized as asolid or firm surface against the posterior vaginal wall forsacrocolpopexy mesh to be sutured to the posterior vaginal wall.Additionally, the curves of second sides 14, 36 allow obturator 20 to bepushed further into interstitial space 13 of sheath 11. Obturator 20 canthus be used to reduce the size of port opening 30 into the peritonealcavity. In turn, the port leading to the peritoneal cavity can beincreased, decreased, or otherwise customized without changing the sizeor shape of laparoscopic tool 10.

FIGS. 3 and 4 depicts port opening 30 into the peritoneal cavity withobturator 20 in place to block, obstructs, or covers port opening 30, sothat the Y-shaped sacrocolpopexy mesh can be sutured to the posteriorvaginal wall on a firm surface (i.e., first surface 34 of head 24 ofobturator 20). Obturator 20 can thus permit multiple size openings intothe peritoneal cavity, allowing various size ports for the needs ofdifferent surgical procedures, and even placement of a sacrocolpopexymesh fixation needle device through the vaginal wall to hold theY-shaped mesh in place during suturing to the vaginal wall.

In an exemplary operation, distal end 18 of laparoscopic tool 10 isinserted into a vagina of a patient or subject using handles 28. Sheath11 traverses the length of the vagina with port opening 30 of first side12 facing or opening to the posterior vaginal wall and with second side14 facing the anterior vaginal wall along its curve. When port opening30 exposes the desired point of incision on the posterior vaginal wall(e.g., typically at the posterior cul-de-sac), interstitial space 13 ofsheath 11 accommodates insertion of laparoscopic surgical tools (e.g.,instruments, implants, sponges, needles or other objects) to make theappropriate incision and access the peritoneal cavity accordingly.

Sheath 11 and port opening 30 can be utilized as a laparoscopic port byitself to access the peritoneal cavity and lower abdomen of the patient.For example, a fluid (e.g., gas) can be pumped into the peritonealcavity or lower abdomen to obtain and maintain pneumoperitoneum (e.g.,using an air source providing carbon dioxide). Obturator 20 can then beinserted into the proximal end of sheath 11 in proximal end 16 oflaparoscopic tool 10 if an operator or clinician requires a smaller portinto the patient (e.g., for insertion of smaller laparoscopicinstruments) or if the operator/clinician requires the peritoneal cavityof the patient to be sealed off from the external environment (i.e.,exterior space), such as from interstitial space 13 (e.g., in order tomaintain pneumoperitoneum or to suture sacrocolpopexy mesh to theposterior vaginal wall). Access to the posterior cul-de-sac can also bemade by simply cutting through the vagina, posterior to the cervix,without requiring pneumoperitoneum.

When obturator 20 is blocking, covering, or otherwise obstructing portopening 30, access to the desired abdominal or pelvic region can beattained via known techniques, for example laparoscopic proceduresthrough the patient's navel or other port. With obturator 20 in place,the operator or clinician can utilize obturator 20 within sheath 11 as afirm surface against which to suture sacrocolpopexy mesh to theposterior vaginal wall. With sheath 11 in place, the operator orclinician can utilize the curve of second side 14 as a firm surfaceagainst which to suture sacrocolpopexy mesh to the anterior vaginalwall. When the Y-shaped sacrocolpopexy mesh has been sutured to theanterior and posterior vaginal walls (and presumably to the sacrum),laparoscopic tool 10 can be removed from the patient's vagina.

Example 2

If needed, laparoscopic tool 10 can be inserted into the vagina withfirst side 12 positioned along or otherwise facing the anterior vaginalwall. This configuration would permit an incision to be made along theanterior vaginal wall through port opening 30. Further, when obturator20 is inserted into sheath 11 through proximal end 16 of laparoscopictool 10, obturator 20 can provide a solid surface that can be used tofacilitate suturing sacrocolpopexy mesh to the anterior vaginal wall.

Example 3

Although the current specification has focused primarily onsacrocolpopexy procedures, it can be appreciated that the currentinvention has a structure that can be utilized for a variety ofapplications and procedures where access to the patient or subject'sabdominal or pelvic region is desired.

With certain applications including the retrieval of large abdominalmasses and transfer of surgical instruments into the abdominal cavity,the laparoscopic device has the potential to expand the use of thevaginal opening as a natural surgical orifice while preserving the useof small port sites during the laparoscopic surgery. This device allowsfor removal of larger specimens than is possible through the abdomen,without the need for morcellation of tissue or enlarging incisions inthe abdominal wall to remove them.

Glossary of Claim Terms

Aligned or coplanar: This term is used herein to refer to two componentsof a structure being in line with each other or along the substantiallysame plane.

Branch: This term is used herein to refer to a prong of a Y-shaped meshalong the end of the mesh that includes two (2) distinct components orprongs that need to be sutured to the prolapsed anatomical structure.

Curvature: This term is used herein to refer to the measure, shape, ordegree to which a surface is curved.

Curved: This term is used herein to refer to a characteristic of theinvention, when viewed from at least one angle, has a generally crescentshape, with one edge having a concave shape and the opposite edge havinga convex shape. The angulation of the curve, i.e., curvature, may vary,for example having a customized curvature.

Distal: This term is used herein to refer to a location that, duringnormal use, is farther from the clinician using the device and closer tothe patient in connection with whom the device is used

Interstitial space: This term is used herein to refer to a hollow space,i.e. not occupied by a solid, which is bound by one or more solids intwo dimensions. For example, the interstitial space may have a squarecross-section, which is bound in two dimensions by four walls.Alternatively, the interstitial space may have an oval or circularcross-section, which is bound in two dimensions by a tubular structure.

Laparoscopic: This term is used herein to encompass any minimallyinvasive surgical technique, including endoscopy and NOTES. The term isintended to be used in its broadest sense, and not limited to specificlaparoscopic techniques.

Longitudinal side: This term is used herein to refer to a surface of astructure along the longitudinal axis of that structure.

Obturator: This term is used herein to refer to an apparatus or deviceused to block, cover, close, or otherwise obstruct a hole (e.g., portopening) partially or wholly. As used with the current invention, theobturator blocks, covers, closes, or otherwise obstructs the portopening formed in the sheath of the laparoscopic tool.

Ovoid: This term is used herein to refer to having a general ovalstructure, such as an egg-shape in three dimensions.

Patient: This term is used herein to refer to humans, but can alsoinclude any member of the animal kingdom, including mammals, such as butnot limited to, primates including gorillas and monkeys; rodents, suchas mice, fish, reptiles and birds. The patient may be any animalrequiring any surgical therapy, treatment, or prophylaxis. The termtreatment, as used in this definition only, is intended to mean thatregiment described is continued until the underlying disease isresolved, whereas therapy requires that the regiment alleviate one ormore symptoms of the underlying disease. Prophylaxis means that regimentis undertaken to prevent a possible occurrence, such as where apre-cancerous lesion is identified.

Peritoneal cavity: This term is used herein to encompass the abdominalregion and pelvic region of a patient, along with any other region thatmay be accessed via use of a laparoscopic tool.

Port opening: This term is used herein to refer to a regularly- orirregularly-shaped aperture that provides open or fluid communicationbetween the interior of a structure (in which the port opening isformed) and the exterior environment.

Proximal: This term is used herein to refer to a location that, duringnormal use, is closer to the operator or clinician using the device andfarther from the patient in connection with whom the device is used.

Push-pull knob: This term is used herein to refer to a protuberance,handle, or control switch that can be gripped or otherwise used toinsert and retract the obturator from the sheath of the laparoscopictool.

Semi-flat: This term is used herein to refer to a surface that isprimarily planar but can otherwise have minor curvatures in order toform to the underlying tissue being contacts so as to provide a sealablefit between the surface and the tissue.

Substantially: This term is used herein to refer to characteristic beinglargely, if not wholly, that which is specified but so close that thedifference is structurally or functionally insignificant.

User: This term is used herein to refer to any operator or clinicianutilizing the laparoscopic tool of the current invention.

The advantages set forth above, and those made apparent from theforegoing disclosure, are efficiently attained. Since certain changesmay be made in the above construction without departing from the scopeof the invention, it is intended that all matters contained in theforegoing description or shown in the accompanying drawings shall beinterpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended tocover all of the generic and specific features of the invention hereindescribed, and all statements of the scope of the invention that, as amatter of language, might be said to fall therebetween.

What is claimed is:
 1. A laparoscopic tool, comprising: a tubular orovoid elongate sheath having a proximal end and a distal end, saidelongate sheath further having a first longitudinal side and a secondlongitudinal side that enclose an interstitial space, said firstlongitudinal side being semi-flat and said second longitudinal sidebeing curved; a port opening formed in said first longitudinal side atsaid distal end of said elongate sheath, said port opening having alength along said first longitudinal side that is substantially alignedor coplanar with said first longitudinal side, said second longitudinalside connected to said first longitudinal side at a point distal to thespatial confines of said port opening; and an elongate obturator capableof insertion into said interstitial space of said elongate sheath, saidobturator including a shaft disposed within said interstitial space whensaid obturator is inserted into said elongate sheath, said obturatorfurther including a head coupled to said distal end of said shaft, saidhead positioned at said distal end of said elongate sheath when saidobturator is inserted into said elongate sheath, said head of saidobturator having a first side and a second side, said first side of saidhead being substantially flat and filling at least a portion of a spaceor void provided by said port opening within said first longitudinalside of said elongate sheath, said second side being curved and disposedalong said second longitudinal surface of said sheath.
 2. A laparoscopictool as in claim 1, further comprising: a handle connected to saidproximal end of said elongate sheath for controlling said laparoscopictool.
 3. A laparoscopic tool as in claim 1, further comprising: apush-pull knob coupled to said proximal end of said shaft of saidobturator for pushing or pulling said obturator into and out of saidelongate sheath.
 4. A laparoscopic tool as in claim 1, furthercomprising: said second side of said head of said obturator having acurvature that is substantially similar to a curvature of said secondlongitudinal side of said elongate sheath at said distal end of saidelongate sheath.
 5. A laparoscopic tool as in claim 1, furthercomprising: said shaft of said obturator having a diameter or width thatis smaller than a width of said head of said obturator.
 6. Alaparoscopic tool as in claim 1, further comprising: said port openinghave a teardrop shape having a wider width at its most distal point anda narrower width at its most proximal point.
 7. A laparoscopic tool forsuturing a sacrocolpopexy mesh, comprising: a tubular or ovoid elongatesheath having a proximal end and a distal end, said elongate sheathfurther having a first longitudinal side and a second longitudinal sidethat enclose an interstitial space, said first longitudinal side beingsemi-flat and said second longitudinal side being curved; ateardrop-shaped port opening formed in said first longitudinal side atsaid distal end of said elongate sheath, said port opening having awider width at its most distal point and a narrower width at its mostproximal point, said port opening having a length along said firstlongitudinal side that is substantially aligned or coplanar with saidfirst longitudinal side, said second longitudinal side connected to saidfirst longitudinal side at a point distal to the spatial confines ofsaid port opening; an elongate obturator capable of insertion into saidinterstitial space of said elongate sheath, said obturator including ashaft disposed within said interstitial space when said obturator isinserted into said elongate sheath, said obturator further including ahead coupled to said distal end of said shaft, said head positioned atsaid distal end of said elongate sheath when said obturator is insertedinto said elongate sheath, said shaft having a diameter or width that issmaller than a width of said head of said obturator, said head of saidobturator having a first side and a second side, said first side of saidhead being substantially flat and filling at least a portion of a spaceor void provided by said port opening within said first longitudinalside of said elongate sheath, said second side being curved and disposedalong said second longitudinal surface of said sheath, said second sideof said head of said obturator having a curvature that is substantiallysimilar to a curvature of said second longitudinal side of said elongatesheath at said distal end of said elongate sheath; a handle connected tosaid proximal end of said elongate sheath for controlling saidlaparoscopic tool; and a push-pull knob coupled to said proximal end ofsaid shaft of said obturator for pushing or pulling said obturator outof said elongate sheath.
 8. A method of treating pelvic organ prolapsein a female patient, comprising the steps of: inserting a laparoscopictool into a vagina of said female patient, said laparoscopic toolincluding an elongate sheath having a semi-flat side and a curved side,said laparoscopic tool further including a port opening formed in saidsemi-flat side; making an incision through said port opening wheredesired by a user; accessing a peritoneal cavity of said female patientthrough said incision; inserting an elongate obturator through saidelongate sheath to reduce the size of said port opening, said obturatorincluding a shaft and a head coupled to a distal end of said shaft, saidhead having a substantially flat side and a curved side, wherein saidsubstantially flat side of said head is positioned substantially withinsaid port opening and said curved side of said head is positioned alonga distal end of said curved side of said sheath; suturing asacrocolpopexy mesh to said vagina using said first side of said head ofsaid obturator, said second side of said sheath, or a combinationthereof as one or more firm surfaces against which said user can suturesaid sacrocolpopexy mesh to said vagina.
 9. A method of treating pelvicorgan prolapse as in claim 8, further comprising: said sacrocolpopexymesh being a Y-shaped mesh with two (2) branches on an end of saidY-shaped mesh.
 10. A method of treating pelvic organ prolapse as inclaim 9, further comprising the steps of: during insertion of saidlaparoscopic tool in said vagina of said female patient, positioningsaid semi-flat side of said sheath and said port opening against aposterior vaginal wall of said vagina; during insertion of saidlaparoscopic tool in said vagina of said female patient, positioningsaid curved side of said sheath against an anterior vaginal wall of saidvagina; suturing a first branch of said two (2) branches of saidY-shaped mesh against said posterior vaginal wall using saidsubstantially flat side of said head of said obturator as a first firmsurface against which said user can suture said first branch of saidY-shaped mesh to said posterior vaginal wall; and suturing a secondbranch of said two (2) branches of said Y-shaped mesh against saidanterior vaginal wall using said curved side of said head of saidobturator as a second firm surface against which said user can suturesaid second branch of said Y-shaped mesh to said anterior vaginal wall.11. A method of treating pelvic organ prolapse as in claim 8, furthercomprising: said incision made in a posterior cul-de-sac of said femalepatient through said port opening of said laparoscopic tool in order toaccess said peritoneal cavity of said female patient.
 12. A method oftreating pelvic organ prolapse as in claim 8, further comprising: saidlaparoscopic tool further including a push-pull knob coupled to aproximal end of said shaft of said obturator for pushing or pulling saidobturator into and out of said elongate sheath.
 13. A method of treatingpelvic organ prolapse as in claim 8, further comprising: said curvedside of said head of said obturator having a curvature that issubstantially similar to a curvature of said curved side of saidelongate sheath at a distal end of said elongate sheath.
 14. A method oftreating pelvic organ prolapse as in claim 8, further comprising: saidshaft of said obturator having a diameter or width that is smaller thana width of said head of said obturator.
 15. A method of treating pelvicorgan prolapse as in claim 8, further comprising: said port opening havea teardrop shape having a wider width at its most distal point and anarrower width at its most proximal point.